Commentary, Information and Discussion on the Darvocet Cause

We have potential representatives from about 17 states. It would be helpful to know what state your are from and also whether you would be willing to head up a letter campaign to Dr. Sebelius at HH&S. Letters similar to whats on the blog “The darvocet cause.” We need to pursue this more agressively.

I have contacted the NY Times and will call them the end of this week , hopefully to convince them there is a story here. I will also contact the WSJ again. Whoever has media contacts go for it!

Here is the copy of the letter I sent to Dr. Sebelius for your review and comment.

Barbara

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August 22, 2011

Dr. Kathleen Sebelius

Secretary of Health and Human Services

200 Independence Ave. S.W.

Washington, D.C. 20201

Re: Darvocet Citizen’s Petition

Dear Dr. Sebelius:

I am the attorney who filed the formal Citizen’s Petition on behalf of myself and other similarly situated individuals, requesting that the FDA revoke the recall of Darvocet. A supplemental petition was also filed and enclosed in a letter to Dr. Margaret Hamburg advising that numerous lawsuits have been filed throughout the country by the plaintiff”s bar, naming 12 plus manufacturers as defendants. Those actions are now consolidated in Multi-District Litigation (The MDL) in Eastern Kentucky. (The purpose of the MDL is to consolidate the discovery). It is anticipated that once discovery is commenced that the circumstances of this recall will not “paint” the FDA in a very a “good light”, meaning the recall was politically motivated.

I have indicated that it is my intention, once Administrative Procedures are exhausted, to file a declaratory judgment action (DJA) in federal court. The basis for the DJA is to have the court find , as a matter of law, that the FDA has failed to follow its own policies and procedures, in recalling this drug. I believe I can prevail on that. One need look no further then the media to see that this has become the rule and not just an anomaly.

I have written to Dr. Hamburg, who didn’t give me the courtesy of a reply. Everyone is busy, so that’s not an excuse. Also, I’m paying her salary and yours as well. In addition, my dealings with various individuals at CDER has been unproductive and for the most part “stonewalling”. What happen to “transparency” and being “for the people” not the “politicians”. After waiting 6 months for a decision on the petition, the FDA elected to give itself a continuance, claiming the issues are complex. There is nothing complex in FDA determining whether it followed its own policies and procedures in recalling this drug. More significantly, many people are left without a remedy and in chronic pain, for no apparent reason.

I would request you review the petition , supplement and attachments, and if you can find any evidence that Darvocet causes heart problems that the source be identified. An unidentified pharmacist at the FDA confirmed that the only study correlating Darvocet with heart problems is the Xanadyne Study done at the request and direction of the FDA. That study consisted of 18 individuals (including controls), two of whom dropped out of the study. The individuals in the study were administered 2- 3 times the therapeutic dose of Darvocet. As result, the data is not statistically significant and the interpretation of that data is not without it’s flaws, as pointed out in the actual report. That report is attached to the Citizen’s Petition.

The drug was removed from the market in other countries because of accidental or intentional overdose, not heart problems. No doubt this can be the basis for removal of the hydrocodones as well. Of interest is that the FDA recommended Lortab, Vicodin, Oxycontin etc. as substitutes. What, these drugs are less prone to overdose and addiction etc.? To the contrary.

If this drug had significant side effects this should have been apparent years ago, given its long history of use having been on the market since 1957. Surely, if this drug caused significant side effects why would CDER advise certain individuals that the drug could be purchased in Australia? There are no alternatives for many people, Darvocet is the only drug that works, the recall needs to be revoked.

If there are concerns regarding Darvocet use then, “black box” it and have patients sign a waiver, but don’t remove the only drug that provides a decent quality of life for many. I would appreciate it if you would look into this as soon as possible. I am willing to come to Washington to discuss this with you.

Attached are samples of two letters that would be helpful if you could fill in the blanks and send to Dr. Sebelius. The longer letter is for the patient to fillout and the other for a friend, relative etc. Send the letter return receipt requested. We really need to get her attention. I have sent my own letter which I will copy you on tomorrow. Also, I working on a letter to the editor I will also copy you on. I am hopeing to get the media involved shortly.

Finally, I started this blog “The Darvocet Cause” to enable an exchange of idea’s on how to get this drug on the market again, so input would be appreciated.

Looking forward to hearing from you all,

Barbara

Dr. Kathleen Sebelius

Secretary of Health and Human Services

200 Independent Ave. S.W.

Washington, D.C 20201.

Dear Dr. Sebelius

My________(son, daughter, relative, friend) was using Darvocet/Propoxphene for _______.This was the only drug that allowed my _____ to have a fairly good quality of life.

Prior to the recall my______ could do________. Since the recall_____(he, she, my friend etc) can no longer do ______or does so in extreme pain. Also, the personalty changes have been significant because of having to live in chronic pain, so it affects everyone.

My_______has tried other pain medications, such as________. Either these don’t work or the side effects are too severe. I would implore you to assist in getting this drug back on the market.

Thank you,

OR

DATE

Address

Dear______

I am participating in a formal citizen’s petition and supplement filed with FDA in mid-January 2011 to revoke the recall of Darvocet/Propoxphene. After waiting for approximately 6 months the FDA didn’t issue a decision, but instead opted to continue its evaluation. Because there is still no decision (no other pain medications work or have too many side affects) my quality of life remains severe compromised.

I suffer from_________ which causes me severe pain and has affected my life in the following ways:______________. Prior to the recall I had been using Darvocet/ Propoxphene for ___)years ,with no adverse effects. Since its recall I have tried _______ which causes me________. So, I have no other alternatives and now my quality of life is severely affected. Shouldn’t it be my decision (after being informed of the side effects) whether the “benefits outweigh the risks” of using Darvocet.?

This drug has been on the market since 1957, if it causes heart problems that would have been apparent a long time ago. One study with questionable results doesn’t justify removing the one pain medication that affords me a decent quality of life. The drug was removal in the US and other countries because of misuse, either accidentally or intentionally, that does n’t justify the recall.

No doubt if there was reliable scientific data to support the removal, that it causes heart problems, I would be part of this recall. Please look into this matter and help get this drug back on the market. Everybody has the right to decide the risks they want to take and the quality of life they want to live.

I haven’t forgotten you, I have been focusing on the status of the Darvocet lawsuits mulitple plaintiff’s have filed claiming cardiotoxicity. I spoke to the individual overseeing the evalution of the petition to get the status. As most of you know we are coming up on the deadline for FDA to respond. I’ve been told we will receive some type of response within the deadline. This could be agreeing to revoke the recall, disagreeing or requesting additional time. Hardly helpful, but at least there is an indication we will hear any day. As soon as I know I will post the decision on this blog .

Keep in mind that I am hopeful but wouldn’t be surprised if it was denied. It was always my expectation that I would have to file suit in federal court. Filing the petition was required before I could bring a federal action. In the event an action is filed I believe there is a good possibilty of prevailing-no guarantees. have faith.

Finally, there are manufacturers willing to produce Darvocet, but are concerned about liability.